Opportunities In Personalised Medicine Industry On Prescient’s Radar

Clinical stage oncology company, Prescient Therapeutics Limited (ASX: PTX) is engaged in developing personalised medicines to treat a range of challenging cancers. The company is known for having one of the deepest clinical pipelines on ASX, with two unique drugs, PTX-100 and PTX-200, under clinical trials at the world-renowned US cancer centres.

Both PTX-100 and PTX-200 work by blocking the survival pathways of growth molecules, particularly Ras (PTX-100) and AKT (PTX-200) that play a dominant role in the development of cancerous cells in several types of cancers including breast cancer, ovarian cancer and Acute Myeloid Leukemia (AML).

Prescient’s drugs block the AKT and Ras growth signals, turning the ‘master switches’ off to let the cancer cells die. In recent times, targeted and personalised cancer therapies have gained momentum, with several positive developments aiming at Ras pathways. The decades of research in the field has shown how genetic mutations allow some cancers to grow, creating an array of targets for drug makers.

Prescient, therefore, focuses on capitalising this opportunity by addressing specific mutations that drive cancer. Prescient presently works on ‘basket approach’ to assess PTX-100 in multiple cancers, wherein it groups patients in accordance with the mutation profile of their tumour, rather than tumour origin.

The basket strategy has been successfully pioneered by several United States’ companies as a faster and enhanced method to identify cancer patients who will potentially benefit from the targeted therapy. Loxo Oncology, Inc is one of those US companies which is closely working towards the genetically defined cancers through the development of highly selective medicines.

Prescient’s progress towards this approach marks the recent launch of the Phase 1b trial of its second targeted anti-cancer drug PTX-100. In the study, researchers will reportedly monitor the mutational status of patients’ malignancies and pursue to correlate this status with the clinical development of PTX-100 in Australia. The core objective of this study is to identify the optimal schedule and dose-dependent effect of multiple doses of PTX-100 in varied types of malignancies including T-cell lymphomas, myeloma, gastric and pancreatic cancers with RhoA and Ras mutations.

Commenting on the start of Phase 1b Clinical Trial of PTX-100, Managing Director and CEO of Prescient, Steven Yatomi-Clarke stated: “Not many companies can boast an anti-cancer drug that is first-in-class entering the clinic.” He added that PTX-100 is a truly unique inhibitor that disrupts oncogenic Ras pathways downstream in patients with advanced solid tumours, demonstrating Prescient’s ability to progress important new cancer therapies.

In the release dated 11 July 2019, Prescient informed that Phase 1b clinical trial would be conducted under the guidance of lead investigator Professor H. Miles Prince. Melbourne-based Professor Price is a prominent international oncologist and has played a key role in the development of many new cancer treatments including Takeda’s brentuximab vedotin; Merck’s vorinostat; and Amgen’s carfilzomib, among others.

The phase includes the open-label trial that would enrol up to 24 patients to evaluate the safety and efficacy of two different doses of PTX-100 besides investigating the pharmacokinetics and pharmacodynamics of the drug. PTX-100 is to be infused intravenously in patients with solid cancers over 60 minutes on days one to five of a 14-day cycle. It follows the encouraging results of the Phase 1 trial, which demonstrated that PTX-100, licensed from Yale University, is well tolerated and achieved stable disease.

Steven Yatomi-Clarke stated that commencing this novel study is another step forward in Prescient’s goal of developing a strong pipeline of personalised cancer therapies.

The entire concept of specific mutation focused on Ras pathway has taken a surge in industry. In the initial stage, the industry’s interest was driven by the Phase 1 studies conducted by multinational biopharmaceutical company Amgen for its Ras inhibitor AMG-510 in May 2019. In June 2019, Amgen published the 1st data for K-Ras inhibitor (AMG-510) at American Society of Clinical Oncology, showing that the drug has been successful in curtailing tumour growth among most of the patients with colorectal cancer and lung cancer.

Prescient explained that this development has strengthened the industry’s attention on Ras as a drug target; whereas, it was earlier recognised as an essential but ‘undruggable’ target. But still, there are not enough targeted treatments available for these mutations, mainly due to the lack of binding sites on the protein, told PTX.

In comparison to Amgen’s drug, which targets a small proportion of K-Ras carrying a particular mutation, PTX-100 highlight its potential to inhibit both the K-Ras and N-Ras pathways regardless of the particular mutation.

Big valuations and deal activity in this space (Source: Company Announcement)

Some big financial news of the industry includes the acquisition of US-based Loxo Oncology, Inc by Eli Lilly and Company for US$8 Billion in January 2019. Also, the biotech giant Array BioPharma was taken over by pharmaceutical company Pfizer in a US$11.4 billion deal to gain access to the Array’s portfolio of promising targeted cancer medicines. It is worth noting that PTX’ head of manufacturing Dr Mike Preigh and head of business development Dr Jim Winkler were formerly both key members of the Array BioPharma team.

The sector also viewed strong support from investors in the recent capital raising program of California-based Revolution Medicines, which successfully secured US$100 million capital to fund the development of its pipeline focused on Ras-dependent cancers.

As at 30 June 2019, cash balance of the company stood at A$9.64 million, including the proceeds from the non-renounceable rights issue and the second tranche of $9.1 million placement.

Prescient’s stock price surged up 2.222% to close at $0.046 on 05 August 2019. Moreover, the stock has witnessed a positive price change of 15.38% in the past one month.

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Also Read: Journey of Prescient Therapeutics in 2019.